The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Clinical Center (CC) for a seven-year program, the NHLBI Clinical Trials Research Network for the Prevention and Early Treatment of Acute Lung Injury (PETAL Network). The purpose of this announcement is to provide a Presolicitation Notice for the release of Solicitation NHLBI-HR-14-03. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION.

The Network will develop and conduct randomized controlled clinical trials to prevent, treat, and/or improve the outcome of patients with or at risk for Acute Lung Injury (ALI). More than one trial will be conducted simultaneously and it is expected that multiple, complex trials will be completed during the course of the contract. The emphasis is expected to be on prevention and early treatments. The Network will consist of approximately eleven Clinical Centers (CCs), each with at least one other recruiting site, and a CCC. Each CC will have two investigators from one institution. The principal investigator will be a qualified intensive care clinician scientist (does not have to be Pulmonary) and the other clinical investigator will be from another specialty, such as an emergency department clinician, with early access to patients at risk for lung injury. The CCs shall also include at least one other institution that will participate in enrollment and study conduct but not network leadership. Each CC will be expected to enroll a total of 220 subjects over 5 ½ years of a seven-year project.

The Co-Investigators (Co-I) from the 12 main CCs will contribute substantially to the trials' scientific leadership and operational management. CC Co-Is will participate in Steering Committee and other subcommittees meetings. The CCs will work collaboratively with the CCC to develop, prioritize, and conduct clinical trials in critically ill patients. CCs will collect data at the local level in accordance with the trial and manuals of operational procedures, transmit data to the CCC, and manage each participant's treatment. CCs will also participate in developing a plan to carry out biospecimen collection from critically ill patients that can be archived for future measurement of longitudinal molecular phenotypes. Research conducted by this network should utilize the most modern and flexible electronic data collection, transfer, decision support, and monitoring. Members of the Network will be encouraged to develop and participate in a collaborative Institutional Review Board (IRB) program to reduce the time and redundancy of protocol approvals and monitoring.

The CCC will coordinate all aspects of the research, including development of protocols, management and analysis of data, and assurance of data quality. The CCC will be responsible for collecting and archiving biospecimens during the contract and depositing the specimens in the NHLBI biorepository at the end of each study.

Project Requirements

The CC is expected to fulfill the following:

1) Experienced and highly competent in multi-center clinical trials in critically ill patients with or at risk for ALI.

2) The PI will be a critical care clinician investigator. The other Co-I, from the same institution, will represent another specialty such as an emergency department physician who can identify at risk patients.

3) Capable of proposing and working collaboratively with other CCs and the CCC to select and develop at least 2 clinical treatment protocols in the first year. Protocols are expected to emphasize prevention and early treatment, but treatments for established ALI and/or very high priority observational studies may be conducted if they have high potential to improve patient outcomes.

4) Participate in developing a scheme to collect biospecimens that can be archived for future longitudinal molecular phenotyping studies of critically ill patients from being at risk until recovery from ALI.

5) Assist with the development of an efficient Network IRB review process to enhance timeliness and value of IRB reviews e. g., collaborative or central IRB.

6) Participate in subcommittees including protocol development and writing committees, publications, sub-studies, ethics, enrollment and others, as necessary.

7) Enroll a minimum of 40 patients per year; oversee or obtain informed consent, and collect and transmit screening and enrollment data to the CCC. Collect and send high quality biospecimens as described in protocols.

8) Conduct regular site-coordination meetings that review screening enrollment practices, data quality and accuracy, oversight of patient care, and adherence to protocols. If coordinators do not have clinical background, activities to supplement medical knowledge must be carried out.

9) Serve as a protocol PI, as appropriate.

10) Coordinate with the CCC to train staff in Network protocols and procedures, including 1) care and treatment of critically ill patients as described in approved protocols; 2) bedside data collection and possibly use of decision support tools; 3) collection, processing, and shipping of specimens to the network central laboratory; 4) clinical testing, extraction of clinical data from medical records, data entry, and transmission of clinical data to the CCC; and 5) adverse and unexpected event reporting.

11) Participate in regular meetings and teleconferences of the PIs and research coordinators to monitor trial and Network progress, identify problems, and develop solutions.

12) Work collaboratively with other CCs and with the CCC to develop new protocols ensuring an available new protocol at all times.

13) Participate in site visits, as needed.

14) Participate in writing final reports and data sets.

This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. This advertisement does not commit the Government to award a contract.

The RFP will be available on the FedBizOpps Web page at http://www.fedbizopps.gov. Prospective offerors are responsible for downloading the RFP and all attachments. The offeror is responsible for monitoring the FedBizOpps Web page for the release of the solicitation and any amendments. The RFP will be available from the FedBizOpps on or about May 18, 2012.